(75 days)
Not Found
No
The document describes sterilization pouches and their compatibility with various sterilization systems. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
Explanation: This device is a sterilization containment pouch designed to hold other medical devices during the sterilization process. It does not directly provide therapy or treatment to a patient.
No
Explanation: This device is a sterilization containment pouch designed to hold medical devices for sterilization. It does not perform any diagnostic functions.
No
The device is a physical sterilization pouch made of Tyvek/plastic film, not software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Intended Use: The intended use of the Vis-U-All Low Temperature Sterilization Pouches/Tubing is to contain medical devices for sterilization by healthcare providers. This is a process related to preparing medical devices for use, not for testing patient samples.
- No mention of testing patient samples: The text describes the types of medical devices that can be pouched and the sterilization cycles they are compatible with. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, the Vis-U-All Low Temperature Sterilization Pouches/Tubing are considered sterilization containment devices, not IVDs.
N/A
Intended Use / Indications for Use
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:
- medical devices in a single or double pouch configuration*
- trays containing medical devices in a single or double pouch configuration
- small items requiring surface sterilization in a single pouch configuration within a tray
*3-D printed items should not be double pouched.
to be sterilized in the:
- Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast and Specialty Cycles of the V-PRO® Low Temperature Sterilization Systems
- Default Cycle of the STERRAD** 100S Sterilizer
- Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear** Technology Sterilizers
- Express, Standard, Flex Scope and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers
**STERRAD and ALLClear are trademarks of Advanced Sterilization Products
NOTE: Trays must be legally marketed for use in the V PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed.
The pouches maintain the sterility of the enclosed devices until used.
When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.
V-PRO 60 & s2 Lumen Cycle
- Non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
- Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
- Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations:
- single or dual lumen devices
- 0.77 mm internal diameter (ID) and 30% RH using 100% ETO (750-790 mg/L)
- single or dual lumen devices
- 4.5 hour exposure at 100(±5) °F, * >30% RH using 100% ETO (750-790 mg/L)
*±5 °F is used during sterilization phase following an equilibrium period of 10% of exposure time.
The ethylene oxide process indicator is intended to be used by health care providers with the Vis- U-All Low Temperature Sterilization Pouches to distinguish between processed and unprocessed units.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
The proposed Vis-U-All Low Temperature Sterilization Pouches/Tubing is identical to the predicate and is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in V-PRO or STERRAD Low Temperature Sterilization Systems. As is the predicate device, the proposed device is available as a self seal pouch, a heat seal pouch, or heat seal tubing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care providers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Effective Sterilant Penetration into Pouches (including pouched trays and, if applicable, pouches placed within a tray).
Acceptance Criteria: Worst case test articles shall be reproducibly sterilized under worst case ½ cycle conditions for the 136L V-PRO Sterilizer Specialty Cycle.
Conclusion: PASS
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
August 7, 2023
STERIS Corporation Jennifer Nalepka Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K231500
Trade/Device Name: Vis-U-All Low Temperature Sterilization Pouches Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: May 22, 2023 Received: May 24, 2023
Dear Jennifer Nalepka:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Christopher K. Dugard - S
for Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231500
Device Name
Vis-U-All Low Temperature Sterilization Pouches
Indications for Use (Describe)
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:
· medical devices in a single or double pouch configuration*
· trays containing medical devices in a single or double pouch configuration
· small items requiring surface sterilization in a single pouch configuration within a tray
*3-D printed items should not be double pouched.
to be sterilized in the:
· Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast and Specialty Cycles of the V-PRO® Low Temperature Sterilization Systems
- · Default Cycle of the STERRAD** 100S Sterilizer
- · Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear** Technology Sterilizers
· Express, Standard, Flex Scope and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers
**STERRAD and ALLClear are trademarks of Advanced Sterilization Products
NOTE: Trays must be legally marketed for use in the V PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed.
The pouches maintain the sterility of the enclosed devices until used.
When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.
V-PRO 60 & s2 Lumen Cycle
· Non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
· Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
· Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations:
o single or dual lumen devices
0.77 mm internal diameter (ID) and 30% RH using 100% ETO (750-790 mg/L)
- · 4.5 hour exposure at 100(±5) °F, * >30% RH using 100% ETO (750-790 mg/L)
- *±5 °F is used during sterilization phase following an equilibrium period of 10% of exposure time.
The ethylene oxide process indicator is intended to be used by health care providers with the Vis- U-All Low Temperature FORM FDA 3881 (6/20) Page 4 of 5
6
Sterilization Pouches to distinguish between processed and unprocessed units.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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7
Image /page/7/Picture/1 description: The image shows the STERIS logo. The logo consists of the word "STERIS" in a bold, serif font, with a registered trademark symbol to the right of the "S". Below the word is an image of several horizontal, wavy lines in a light blue color.
510(k) Summary for K231500 Vis-U-All Low Temperature Sterilization Pouches/Tubing
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact: Jennifer Nalepka Manager, Regulatory Affairs
Telephone: (440) 392-7458 e-mail: jennifer_nalepka@steris.com
Submission Date: July 28, 2023
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
8
Device Name 1.
| Trade Name: | Vis-U-All Low Temperature Sterilization
Pouches/Tubing |
|------------------------|-----------------------------------------------------------|
| Device Classification: | Class II |
| Common/Usual Name: | Sterilization pouch |
| Classification Name: | Sterilization wrap |
| Classification Number: | 21 CFR 880.6850 |
| Product Code: | FRG |
2. Predicate Device
Vis-U-All Low Temperature Sterilization Pouches/Tubing, K222400 (Vaporized Hydrogen Peroxide claims)
Vis-U-All Low Temperature Sterilization Pouches/Tubing, K092745 (Ethylene Oxide claims)
3. Description of Device
The proposed Vis-U-All Low Temperature Sterilization Pouches/Tubing is identical to the predicate and is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in V-PRO or STERRAD Low Temperature Sterilization Systems. As is the predicate device, the proposed device is available as a self seal pouch, a heat seal pouch, or heat seal tubing. Available sizes and configurations are shown in Table 5-1.
| Type | Size
(inches unless specified) |
|-----------------|-----------------------------------|
| Heat Seal Pouch | 3 x 7 |
| | 4 x 9 |
| | 4 x 12 |
| | 4 x 22 |
| | 6 x 10 |
| | 8 x 12 |
| | 10 x 15 |
| | 12 x 18 |
| Self Seal Pouch | 3 x 7 |
| | 4 x 9 |
| | 4 x 12 |
| | 4 x 22 |
| | 6 x 10 |
Table 5-1. Sizes and Configurations of Vis-U-All Low Temperature Sterilization Pouches/Tubing
9
| Type | Size
(inches unless specified) |
|--------|-----------------------------------|
| | 8 x 12 |
| | 10 x 15 |
| | 12 x 18 |
| | 8 x 21 |
| | 8 x 27 |
| | 9 x 27 |
| | 11 x 22 |
| | 12 x 27 |
| Tubing | 3" x 100' |
| Tubing | 4" x 100' |
| Tubing | 6" x 100' |
| Tubing | 9" x 100' |
| Tubing | 14" x 100' |
The purpose of this submission is To qualify use of the Vis-U-All Low Temperature Sterilization Pouches and Tubing for extended claims in the V-PRO maX 2 Specialty Cycle. No changes have been made to the device for this claim other than labeling.
Intended Use/ Indications for Use 4.
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:
- medical devices in a single or double pouch configuration .
- trays* containing medical devices in a single or double pouch configuration .
- small items requiring surface sterilization in a single pouch configuration within a ● trav*
*3-D printed items should not be double-pouched.
to be sterilized in the:
- Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast and Specialty Cycles of the V-PRO® Low Temperature Sterilization Systems
- Default Cycle of the STERRAD** 100S Sterilizer ●
- . Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear** Technology Sterilizers
- Express, Standard, Flex Scope and DUO Cycles of the STERRAD 100NX and ● 100NX with ALLClear Technology Sterilizers
**STERRAD and ALLClear are trademarks of Advanced Sterilization Products The pouches maintain the sterility of the enclosed devices until used.
NOTE: Trays must be legally marketed for use in the V-PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed.
10
When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a trav, the tray must fit loosely within the pouch.
V-PRO 60 & s2 Lumen Cycle
- · Non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
- · Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
- · Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes. with the following configurations:
- o single or dual lumen devices
- . ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length
- . ≥ 1.8 mm ID x ≤ 542 mm in length
- o triple lumen devices
- ≥1.2 mm ID and ≤ 275 mm in length .
- . ≥1.8 mm ID and ≤ 310 mm in length or
- ≥2.8 mm ID and ≤ 317 mm in length
V-PRO 60 & s2 Non Lumen Cycle
- · Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors
V-PRO 60 & s2 Flexible Cycle
- · Load 1: One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:
- o single or dual lumen device with lumens that are > 1 mm ID and 1.8 mm ID and 0.48 mm ID and ≤ 100 mm in length.
V-PRO maX 2 Fast Non Lumen Cycle
- · Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
V-PRO maX 2 Specialty Cycle
- Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Patient-specific surgical guides (e.g. osteotomy, shoulder, hip, knee, spine) or anatomical models fabricated via additive manufacturing (3D printing) processes and intended for single-use during operative procedures
12
- The validation studies were conducted using a validation load consisting of pouched guide(s) ) (with or without tray) for a total weight of 5 lbs (2.3 kg) 3D printed material.
** The validation studies were conducted using a validation load consisting of one pouched instrument trav or one pouched instrument tray or one pouch with) (with or without tray) for a total weight of 5 lbs (2.3 kg) 3D printed material.
| Material | Manufacturer | Specialty Cycle | Lumens |
|---|---|---|---|
| Surgical Guide Resin | Formlabs | F | ≥3 mm ID x ≤30 mm L |
| BioMed Amber Resin | Formlabs | F | ≥3 mm ID x ≤30 mm L |
| Dental LT Clear V2 Resin | Formlabs | D | ≥3 mm ID x ≤30 mm L |
| BioMed Clear Resin | Formlabs | D | ≥3 mm ID x ≤30 mm L |
| Biocompatible Clear MED610 | Stratasys | E | ≥3 mm ID x ≤20 mm L |
| Biocompatible Opaque MED615RGD | Stratasys | E | ≥3 mm ID x ≤20 mm L |
| VeroGlaze™ MED620 | Stratasys | E | ≥3 mm ID x ≤20 mm L |
STERRAD 100S Default Cycle
- · Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
- · Metal and nonmetal lumened instruments with:
-
6 mm ID and 1 mm ID and 2 mm ID and 1 mm ID and 1 mm ID and 30% RH using 100% ETO (750-790 mg/L)
4.5 hour exposure at 100(±5) °F, * >30% RH using 100% ETO (750-790 mg/L) .
-
*±5 °F is used during sterilization phase following an equilibrium period of 10% of exposure time.
The ethylene oxide process indicator is intended to be used by health care providers with the Vis-U-All Low Temperature Sterilization Pouches to distinguish between processed and unprocessed units.
5. Description of Safety and Substantial Equivalence
The proposed and predicate devices are single use sterilization pouches for use in V-PRO Sterilizers. Tables 5-2 and 5-3 summarizes the difference between the proposed device and predicate device cleared under K222440 and K092745.
Table 5-2. Technical Comparison to the K222440 Predicate Device (Vaporized Hydrogen Peroxide claims)
| Feature | Vis-U-All Low Temperature Sterilization
Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization
Pouch (K222440) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use / | The Vis-U-All Low Temperature
Sterilization Pouches/Tubing are
sterilization containment pouches for use by | The Vis-U-All Low Temperature
Sterilization Pouches/Tubing are
sterilization containment pouches for use by |
| Feature | Vis-U-All Low Temperature Sterilization
Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization
Pouch (K222440) |
| Indications
for Use | health care providers to enclose:
• medical devices in a single or double
pouch configuration
• trays* containing medical devices in a
single or double pouch configuration
• small items requiring surface sterilization
in a single pouch configuration within a
tray
3-D printed items should not be double-
| health care providers to enclose:
• medical devices in a single or double
pouch configuration
• trays containing medical devices in a
single or double pouch configuration
• small items requiring surface sterilization
in a single pouch configuration within a
tray |
| | pouched
to be sterilized in the:
• Lumen , Non Lumen, Flexible , Fast Non
Lumen and Fast Cycles of the V-PRO ®
Low Temperature Sterilization Systems
• Default Cycle of the STERRAD** 100S
Sterilizer
• Standard and Advanced Cycles of the
STERRAD NX and NX with
ALLClear** Technology Sterilizers
• Express, Standard, Flex Scope and
DUO Cycles of the STERRAD 100NX
and 100NX with ALLClear Technology
Sterilizers
**STERRAD and ALLClear are trademarks
of Advanced Sterilization Products
NOTE: Trays must be legally marketed for
use in the V PRO Low Temperature or
STERRAD Sterilization Systems and
contain a vent surface area to tray volume
ratio ≥ 0.135 in-1 with the maximum
number of instrument organizers installed. | NOTE: Trays must be legally marketed for
use in the V PRO Low Temperature or
STERRAD Sterilization Systems and
contain a vent surface area to tray volume
ratio ≥ 0.135 in-1 with the maximum
number of instrument organizers installed.
to be sterilized in the:
• Lumen , Non Lumen , Flexible , Fast Non
Lumen and Fast Cycles of the V-PRO ®
Low Temperature Sterilization Systems
• Default Cycle of the STERRAD 100S
Sterilizer
• Standard and Advanced Cycles of the
STERRAD NX and NX with ALLClear
Technology Sterilizers
• Express, Standard, Flex Scope and
DUO Cycles of the STERRAD 100NX
and 100NX with ALLClear Technology
Sterilizers
*STERRAD and ALLClear are trademarks
of Advanced Sterilization Products |
| | The pouches maintain the sterility of the
enclosed devices until used.
When used to enclose medical devices, the
pouches are intended to contain the devices
in such a manner as to leave a minimum of
one inch between the devices and seal on all
sides. When used to enclose a tray, the tray
must fit loosely within the pouch.
Intended Sterilization Cycles and Intended
Pouch Loads when Medical Devices are: | The pouches maintain the sterility of the
enclosed devices until used.
When used to enclose medical devices, the
pouches are intended to contain the devices
in such a manner as to leave a minimum of
one inch between the devices and seal on all
sides. When used to enclose a tray, the tray
must fit loosely within the pouch.
Intended Sterilization Cycles and Intended
Pouch Loads when Medical Devices are: |
| | • Directly pouched
• Placed inside of a tray and the tray
pouched
V-PRO 60 & s2 Lumen Cycle
• Non-lumened devices with diffusion-
restricted spaces such as the hinged | • Directly pouched
• Placed inside of a tray and the tray
pouched
V-PRO 60 & s2 Lumen Cycle
• Non-lumened devices with diffusion-
restricted spaces such as the hinged |
| | portion of forceps and scissors.
• Non-lumened devices including non- | portion of forceps and scissors.
• Non-lumened devices including non- |
| Feature | Vis-U-All Low Temperature Sterilization
Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization
Pouch (K222440) |
| | lumened rigid and semi-rigid endoscopes
• Medical devices, including single, dual
and triple channeled rigid and semi-rigid
endoscopes, with the following
configurations:
single or dual lumen devices
$\ge$ 0.77 mm internal diameter (ID) and $\le$ 410
mm in length
$\ge$ 1.8 mm ID x $\le$ 542 mm in length
triple lumen devices
$\ge$ 1.2 mm ID and $\le$ 275 mm in length
$\ge$ 1.8 mm ID and $\le$ 310 mm in length
Or
$\ge$ 2.8 mm ID and $\le$ 317 mm in length | lumened rigid and semi-rigid endoscopes
• Medical devices, including single, dual
and triple channeled rigid and semi-rigid
endoscopes, with the following
configurations:
single or dual lumen devices
$\ge$ 0.77 mm internal diameter (ID) and $\le$ 410
mm in length
$\ge$ 1.8 mm ID x $\le$ 542 mm in length
triple lumen devices
$\ge$ 1.2 mm ID and $\le$ 275 mm in length
$\ge$ 1.8 mm ID and $\le$ 310 mm in length
Or
$\ge$ 2.8 mm ID and $\le$ 317 mm in length |
| | V-PRO 60 & s2 Non Lumen Cycle
Non-lumened devices including non-
lumened rigid, semi-rigid and flexible
endoscopes and non-lumened devices with
diffusion-restricted spaces such as the
hinged portion of forceps and scissors. | V-PRO 60 & s2 Non Lumen Cycle
Non-lumened devices including non-
lumened rigid, semi-rigid and flexible
endoscopes and non-lumened devices with
diffusion-restricted spaces such as the
hinged portion of forceps and scissors. |
| | V-PRO 60 & s2 Flexible Cycle
Load 1: One flexible surgical endoscope
or bronchoscope with a light cord (if not
integral to endoscope) and mat without
any additional load. The flexible
endoscope may be a:
• single or dual lumen device with lumens
that are $\ge$ 1 mm ID and $\le$ 990 mm in
length
Load 2: Non-lumened devices including
non-lumened rigid semi-rigid , and
flexible endoscopes and non-lumened
devices with diffusion-restricted areas
such as the hinged portion of forceps or
scissors. Medical devices, including rigid
and semi- rigid endoscopes, with the
following configurations:
$\ge$ 0.76 mm ID and $\le$ 233 mm in length
$\ge$ 1.0 mm ID and $\le$ 254 mm in length
$\ge$ 1.8 mm ID and $\le$ 542 mm in length | V-PRO 60 & s2 Flexible Cycle
Load 1: One flexible surgical endoscope
or bronchoscope with a light cord (if not
integral to endoscope) and mat without
any additional load. The flexible
endoscope may be a:
• single or dual lumen device with lumens
that are $\ge$ 1 mm ID and $\le$ 990 mm in
length
Load 2: Non-lumened devices including
non-lumened rigid semi-rigid , and
flexible endoscopes and non-lumened
devices with diffusion-restricted areas
such as the hinged portion of forceps or
scissors. Medical devices, including rigid
and semi- rigid endoscopes, with the
following configurations:
$\ge$ 0.76 mm ID and $\le$ 233 mm in length
$\ge$ 1.0 mm ID and $\le$ 254 mm in length
$\ge$ 1.8 mm ID and $\le$ 542 mm in length |
| | V-PRO s2 Fast Cycle
Non-lumened devices including non-
lumened rigid and semi-rigid and flexible
endoscopes and non-lumened devices
with diffusion-restricted spaces such as
the hinged portion of forceps and scissors.
• Medical devices (including single, dual
and triple channeled rigid and semi-rigid
endoscopes) with the following
configurations:
single or dual lumen devices | V-PRO s2 Fast Cycle
Non-lumened devices including non-
lumened rigid and semi-rigid and flexible
endoscopes and non-lumened devices
with diffusion-restricted spaces such as
the hinged portion of forceps and scissors.
• Medical devices (including single, dual
and triple channeled rigid and semi-rigid
endoscopes) with the following
configurations:
single or dual lumen devices |
| Feature | Vis-U-All Low Temperature Sterilization
Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization
Pouch (K222440) |
| | $\ge$ 1.8 mm ID x $\le$ 542 mm in length | $\ge$ 1.8 mm ID x $\le$ 542 mm in length |
| | • Triple channeled devices with stainless
steel lumens that are either: | • Triple channeled devices with stainless
steel lumens that are either: |
| | $\ge$ 1.2 mm ID and $\le$ 275 mm in length | $\ge$ 1.2 mm ID and $\le$ 275 mm in length |
| | 1.8mm ID and 310mm in length | 1.8mm ID and 310mm in length |
| | Or | Or |
| | $\ge$ 2.8 mm ID and $\le$ 317 mm in length | $\ge$ 2.8 mm ID and $\le$ 317 mm in length |
| | V-PRO 1, 1 Plus, maX & maX 2
Lumen Cycle | V-PRO 1, 1 Plus, maX & maX 2
Lumen Cycle |
| | • Non-lumened devices with diffusion-
restricted spaces such as the hinged
portion of forceps and scissors. | • Non-lumened devices with diffusion-
restricted spaces such as the hinged
portion of forceps and scissors. |
| | • Non-lumened devices including non-
lumened rigid and semi-rigid
endoscopes | • Non-lumened devices including non-
lumened rigid and semi-rigid
endoscopes |
| | • Medical devices , including single,
dual or triple channeled stainless steel
lumens that are:
$\ge$ 0.77 mm ID and $\le$ 527 mm in length | • Medical devices , including single,
dual or triple channeled stainless steel
lumens that are:
$\ge$ 0.77 mm ID and $\le$ 527 mm in length |
| | $\ge$ 0.8 mm ID and $\le$ 542 mm in length | $\ge$ 0.8 mm ID and $\le$ 542 mm in length |
| | $\ge$ 0.48 mm ID and $\le$ 100 mm in length | $\ge$ 0.48 mm ID and $\le$ 100 mm in length |
| | • Medical devices with Dead end lumens
that are $\ge$ 1.3 mm ID and $\le$ 73 mm in
length | • Medical devices with Dead end lumens
that are $\ge$ 1.3 mm ID and $\le$ 73 mm in
length |
| | • Devices with rigid non-metallic
lumens (such as those used in
endoscope sheaths, take-apart
forceps and trocars) that are: | • Devices with rigid non-metallic
lumens (such as those used in
endoscope sheaths, take-apart
forceps and trocars) that are: |
| | $\ge$ 3 mm ID and $\le$ 298 mm in length | $\ge$ 3 mm ID and $\le$ 298 mm in length |
| | $\ge$ 4 mm ID and $\le$ 424 mm in length | $\ge$ 4 mm ID and $\le$ 424 mm in length |
| | V-PRO 1, 1 Plus, maX & maX2 Non
Lumen Cycle | V-PRO 1, 1 Plus, maX & maX2 Non
Lumen Cycle |
| | Non-lumened devices including non-
lumened rigid, semi-rigid and flexible
endoscopes and non-lumened devices
with diffusion-restricted spaces such as
the hinged portion of forceps and
scissors. | Non-lumened devices including non-
lumened rigid, semi-rigid and flexible
endoscopes and non-lumened devices
with diffusion-restricted spaces such as
the hinged portion of forceps and
scissors. |
| | V-PRO maX and maX 2 Flexible Cycle | V-PRO maX and maX 2 Flexible Cycle |
| | Load 1: Single or dual lumen surgical
flexible endoscopes (such as those used
in ENT, Urology and Surgical Care) and
bronchoscopes with a light cord (if not
integral to endoscope) and mat with no
additional load. | Load 1: Single or dual lumen surgical
flexible endoscopes (such as those used
in ENT, Urology and Surgical Care) and
bronchoscopes with a light cord (if not
integral to endoscope) and mat with no
additional load. |
| | The flexible endoscopes may
contain either a single or dual
channel lumen that is > 1 mm ID
and 1 mm ID
and 30%
RH using 100% ETO (750-790 mg/L)
• 4.5 hour exposure at 100(±5) °F, *
30% RH using 100% ETO (750-790
mg/L)
*±5 °F is used during sterilization phase
following an equilibrium period of 10%
of exposure time. | |
| Feature | Vis-U-All Low Temperature Sterilization
Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization
Pouch (K222440) |
| | The ethylene oxide process indicator is
intended to be used by health care
providers with the Vis- U-All Low
Temperature Sterilization Pouches to
distinguish between processed and
unprocessed units. | |
| Device
Features | • Chevron end of pouches for ease of
opening
Chemical process indicator for EO | • Chevron end of pouches for ease of
opening
Chemical process indicator for EO |
| Maintenance
of Sterility | 1 year | 1 year |
| Materials of
Construction | Tyvek and plastic | Tyvek and plastic |
| Types | Self Seal, Heat Seal, Tubing | Self Seal, Heat Seal, Tubing |
including instruments which have diffusion-
restricted spaces, such as the hinged portion
including instruments which have diffusion-
restricted spaces, such as the hinged portion
19
20
Table 5-3. Technical Comparison to the K092745 Predicate Device (Ethylene Oxide Claims)
| Feature | Vis-U-All Low Temperature Sterilization
Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization
Pouch (K092745) |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use /
Indications
for Use | The Vis-U-All Low Temperature
Sterilization Pouches/Tubing are
sterilization containment pouches for use by
health care providers to enclose:
• medical devices in a single or double
pouch configuration
• trays* containing medical devices in a
single or double pouch configuration
• small items requiring surface sterilization
in a single pouch configuration within a
tray
3-D printed items should not be double-
pouched | The Vis-U-All Low Temperature Sterilization
Pouch has been qualified by STERIS as
suitable for use by health care providers to
enclose and seal other medical devices to be
sterilized by ethylene oxide (ETO). The Vis-
U-All Low Temperature Sterilization Pouch
for ethylene oxide is designed to maintain
sterility of properly processed medical devices
during normal handling and storage until the
pouch is opened and the medical device is
removed for use. |
| | to be sterilized in the:
• Lumen , Non Lumen, Flexible , Fast Non
Lumen and Fast Cycles of the V-PRO ®
Low Temperature Sterilization Systems
• Default Cycle of the STERRAD* 100S
Sterilizer
• Standard and Advanced Cycles of the
STERRAD NX and NX with
ALLClear** Technology Sterilizers
Express, Standard, Flex Scope and
DUO Cycles of the STERRAD 100NX
and 100NX with ALLClear Technology
Sterilizers
**STERRAD and ALLClear are trademarks
of Advanced Sterilization Products
NOTE: Trays must be legally marketed for
use in the V PRO Low Temperature or | The following are the validated test
conditions:
• 1 hour exposure, at 130(±5) °F, * >30% RH
using 100% ETO (750-790 mg/L)
• 4.5 hour exposure at 100(±5) °F, * >30%
RH using 100% ETO (750-790 mg/L)
*±5 °F is used during sterilization phase
following an equilibrium period of 10% of
exposure time.
The ethylene oxide process indicator is
intended to be used by health care providers
with the Vis- U-All Low Temperature
Sterilization Pouches to distinguish between
processed and unprocessed units. |
| Feature | Vis-U-All Low Temperature Sterilization
Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization
Pouch (K092745) |
| | STERRAD Sterilization Systems and | |
| | contain a vent surface area to tray volume | |
| | ratio $\ge$ 0.135 in-1 with the maximum | |
| | number of instrument organizers installed. | |
| | The pouches maintain the sterility of the
enclosed devices until used. | |
| | When used to enclose medical devices, the | |
| | pouches are intended to contain the devices | |
| | in such a manner as to leave a minimum of | |
| | one inch between the devices and seal on all | |
| | sides. When used to enclose a tray, the tray | |
| | must fit loosely within the pouch. | |
| | Intended Sterilization Cycles and Intended | |
| | Pouch Loads when Medical Devices are: | |
| | • Directly pouched
• Placed inside of a tray and the tray | |
| | pouched | |
| | | |
| | V-PRO 60 & s2 Lumen Cycle
• Non-lumened devices with diffusion- | |
| | restricted spaces such as the hinged | |
| | portion of forceps and scissors. | |
| | • Non-lumened devices including non- | |
| | lumened rigid and semi-rigid endoscopes | |
| | • Medical devices , including single, dual | |
| | and triple channeled rigid and semi-rigid | |
| | endoscopes, with the following
configurations: | |
| | single or dual lumen devices | |
| | $\ge$ 0.77 mm internal diameter (ID) and $\le$ 410 | |
| | mm in length | |
| | $\ge$ 1.8 mm ID x $\le$ 542 mm in length | |
| | triple lumen devices | |
| | $\ge$ 1.2 mm ID and $\le$ 275 mm in length | |
| | $\ge$ 1.8 mm ID and $\le$ 310 mm in length
Or | |
| | $\ge$ 2.8 mm ID and $\le$ 317 mm in length | |
| | | |
| | V-PRO 60 & s2 Non Lumen Cycle | |
| | Non-lumened devices including non- | |
| | lumened rigid, semi-rigid and flexible
endoscopes and non-lumened devices with | |
| | diffusion-restricted spaces such as the | |
| | hinged portion of forceps and scissors. | |
| | V-PRO 60 & s2 Flexible Cycle | |
| | Load 1: One flexible surgical endoscope | |
| | or bronchoscope with a light cord (if not | |
| | integral to endoscope) and mat without | |
| | any additional load. The flexible | |
| | endoscope may be a: | |
| | • single or dual lumen device with lumens | |
| Feature | Vis-U-All Low Temperature Sterilization
Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization
Pouch (K092745) |
| | length | |
| | Load 2: Non-lumened devices including
non-lumened rigid semi-rigid, and
flexible endoscopes and non-lumened
devices with diffusion-restricted areas
such as the hinged portion of forceps or
scissors. Medical devices, including rigid
and semi- rigid endoscopes, with the
following configurations: | |
| | ≥ 0.76 mm ID and ≤ 233 mm in length | |
| | ≥ 1.0 mm ID and ≤ 254 mm in length | |
| | ≥ 1.8 mm ID and ≤ 542 mm in length | |
| | V-PRO s2 Fast Cycle | |
| | • Non-lumened devices including non-
lumened rigid and semi-rigid and flexible
endoscopes and non-lumened devices
with diffusion-restricted spaces such as
the hinged portion of forceps and scissors. | |
| | • Medical devices (including single, dual
and triple channeled rigid and semi-rigid
endoscopes) with the following
configurations: | |
| | o single or dual lumen devices
≥ 0.77 mm ID and ≤ 410 mm in length
≥ 1.8 mm ID x ≤ 542 mm in length | |
| | • Triple channeled devices with stainless
steel lumens that are either:
≥1.2 mm ID and ≤ 275 mm in length
1.8mm ID and 310mm in length
Or
≥2.8 mm ID and ≤ 317 mm in length | |
| | V-PRO 1, 1 Plus, maX & maX 2
Lumen Cycle | |
| | • Non-lumened devices with diffusion-
restricted spaces such as the hinged
portion of forceps and scissors. | |
| | • Non-lumened devices including non-
lumened rigid and semi-rigid
endoscopes | |
| | • Medical devices , including single,
dual or triple channeled stainless steel
lumens that are: | |
| | ≥ 0.77 mm ID and ≤ 527 mm in length
≥ 0.8 mm ID and ≤ 542 mm in length
≥ 0.48 mm ID and ≤ 100 mm in length | |
| | • Medical devices with Dead end lumens
that are ≥ 1.3 mm ID and ≤ 73 mm in
length | |
| | • Devices with rigid non-metallic
lumens (such as those used in
endoscope sheaths, take-apart
forceps and trocars) that are: | |
| Feature | Vis-U-All Low Temperature Sterilization
Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization
Pouch (K092745) |
| | $\ge$ 4 mm ID and $\le$ 424 mm in length | |
| | V-PRO 1, 1 Plus, maX & maX2 Non Lumen Cycle
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors. | |
| | V-PRO maX and maX 2 Flexible Cycle
Load 1: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
The flexible endoscopes may contain either a single or dual channel lumen that is > 1 mm ID and V-PRO maX 2 Fast Non Lumen Cycle
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors. | |
| | V-PRO maX 2 Specialty Cycle:
Patient-specific surgical guides (e.g. osteotomy, shoulder, hip, knee, spine) or anatomical models fabricated via additive manufacturing (3D printing) processes and intended for single-use during operative procedures.*
or
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.**
- The validation studies were conducted using | |
21
22
23
24
| Feature | Vis-U-All Low Temperature Sterilization
Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization
Pouch (K092745) | | | |
|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|--------------------|------------------------|--|
| | guide(s)/model(s) (with or without tray) for a
total weight of 5 lbs (2.3 kg) 3D printed
material.
** The validation studies were conducted
using a validation load consisting of one
pouched instrument tray or one pouched
instrument tray or one pouch with
guide(s)/model(s) (with or without tray) for a
total weight of 11 lbs (5 kg). | | | | |
| | Material | Manufacturer | Specialty
Cycle | Lumens | |
| | Surgical Guide
Resin | Formlabs | F | ≥3 mm ID x
≤30 mm L | |
| | BioMed Amber
Resin | Formlabs | F | ≥3 mm ID x
≤30 mm L | |
| | Dental LT Clear
V2 Resin | Formlabs | D | ≥3 mm ID x
≤30 mm L | |
| | BioMed Clear
Resin | Formlabs | D | ≥3 mm ID x
≤30 mm L | |
| | Biocompatible
Clear MED610 | Stratasys | E | ≥3 mm ID x
≤20 mm L | |
| | Biocompatible
Opaque
MED615RGD | Stratasys | E | ≥3 mm ID x
≤20 mm L | |
| | VeroGlaze™
MED620 | Stratasys | E | ≥3 mm ID x
≤20 mm L | |
| | STERRAD 100S Default Cycle
Metal and nonmetal medical devices
including instruments which have diffusion-
restricted spaces, such as the hinged portion
of forceps and scissors.
Metal and nonmetal lumened instruments
with:
≥ 6 mm ID and ≤ 310 mm in length
Medical devices with a single stainless steel
lumen with:
≥ 1 mm ID and ≤ 125 mm in length
≥ 2 mm ID and ≤ 250 mm in length
≥ 3 mm ID and ≤ 400 mm in length | | | | |
| | STERRAD NX and NX with ALLClear
Technology Standard Cycle
Metal and nonmetal medical devices
including instruments which have diffusion-
restricted spaces, such as the hinged portion
of forceps and scissors.
Medical devices with a single stainless steel
lumen with:
≥ 1 mm ID and ≤ 150 mm in length
≥ 2 mm ID and ≤ 400 mm in length | | | | |
| | STERRAD NX and NX with ALLClear
Technology Advanced Cycle | | | | |
including instruments which have diffusion-
25
| Feature | Vis-U-All Low Temperature Sterilization
Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization
Pouch (K092745) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| | restricted spaces, such as the hinged portion
of forceps and scissors.
Medical Devices, including most flexible
endoscopes, with: | |
| | a single stainless steel lumen with:
$\geq$ 1 mm ID and $\leq$ 500 mm in length
Single channel polyethylene and Teflon
(polytetrafluoroethylene)
$\geq$ 1 mm ID and $\leq$ 850 mm in length | |
| | STERRAD 100NX and 100NX with
ALLClear Technology Standard Cycle
Metal and nonmetal medical devices
including instruments which have diffusion-
restricted spaces, such as the hinged portion
of forceps and scissors.
Medical devices with a single stainless steel
lumen with:
$\geq$ 0.7 mm ID and $\leq$ 500 mm in length | |
| | STERRAD 100NX and 100NX with
ALLClear Technology Flex Scope Cycle
Metal and nonmetal medical devices
including instruments which have diffusion-
restricted spaces, such as the hinged portion
of forceps and scissors.
Medical Devices, including most flexible
endoscopes, with:
☐ Single channel polyethylene and Teflon
(polytetrafluoroethylene)
$\geq$ 1 mm ID and $\leq$ 850 mm in length | |
| | STERRAD 100NX and 100NX with
ALLClear Technology Express Cycle
Metal and nonmetal medical devices
(surfaces sterilization only) and instruments
which have diffusion- restricted spaces ,
such as the hinged portion of forceps and
scissors. | |
| | STERRAD 100NX and 100NX with
ALLClear Technology Duo Cycle
Medical devices including:
most flexible endoscopes with a single
channel of polyethylene and Teflon
(polytetrafluoroethylene) with $\geq$ 1 mm ID
and $\leq$ 875 mm in length
• accessory devices that are normally
connected to a flexible endoscope during
use | |
| | • flexible endoscopes without lumens
Ethylene Oxide Sterilization
The Vis-U-All Low Temperature
Sterilization Pouch has been qualified by | |
| Feature | Vis-U-All Low Temperature Sterilization
Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization
Pouch (K092745) |
| | STERIS as suitable for use by health care
providers to enclose and seal other
medical devices to be sterilized by
ethylene oxide (ETO). The Vis-U-All
Low Temperature Sterilization Pouch for
ethylene oxide is designed to maintain
sterility of properly processed medical
devices during normal handling and
storage until the pouch is opened and the
medical device is removed for use.
The following are the validated test
conditions:
• 1 hour exposure, at 130(±5) °F, * >30%
RH using 100% ETO (750-790 mg/L)
• 4.5 hour exposure at 100(±5) °F, *
30% RH using 100% ETO (750-790
mg/L)
*±5 °F is used during sterilization phase
following an equilibrium period of 10%
of exposure time.
The ethylene oxide process indicator is
intended to be used by health care
providers with the Vis- U-All Low
Temperature Sterilization Pouches to
distinguish between processed and
unprocessed units. | |
| Device
Features | • Chevron end of pouches for ease of
opening
Chemical process indicator for EO | Chevron end of pouches for ease of
opening
Chemical process indicator for EO |
| Maintenance
of Sterility | 1 year | 1 year |
| Materials of
Construction | Tyvek and plastic | Tyvek and plastic |
| Types | Self Seal. Heat Seal. Tubing | Self Seal. Heat Seal. Tubing |
26
Table 5-4 summarizes the testing of the Vis-U-All Low Temperature Sterilization Pouches/Tubing to demonstrate that the proposed pouch is qualified for use in V-PRO Low temperature Sterilization Systems and is as safe, as effective, and performs the same as the predicate device.
Table 5-4. Performance Test Summary
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Effective Sterilant Penetration into | ||
| Pouches (including pouched trays | ||
| and, if applicable, pouches placed | ||
| within a tray): | Worst case test articles shall be | |
| reproducibly sterilized under worst case ½ | ||
| cycle conditions for the 136L V-PRO | ||
| Sterilizer Specialty Cycle | PASS |
27
8. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate devices (K222440, K092745), Class II (21 CFR 880.6850), product code FRG.